Endostar Combination With Chemotherapy and EGFR-TKI in Lung Cancer Rechallenging Treatment After Acquired Resistance.

Peking University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Lung Cancer

Treatments: Drug: Placebo; Drug: Recombinant human endostatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02350361

PekingUTH-LL01

Details and patient eligibility

About

Here we are going to find a method by using available multiple drugs including angiogenesis medicine - Endostar to treat lung cancer patients who acquired resistence from EGFR-TKI but have responsed to it before.

Full description

Lung cancer patients who received epidermal growth factor receptor tyrosine kinase inhibitors(EGFR-TKI) will acquiring resistance to the drug. This is a study of using Endostar, an angiogentic medicine, combination with chemotherapy and EGFR-TKI in lung cancer rechallenging treatment after resistance of EGFR-TKI and progression disease.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with pathologic confirmation of NSCLC with tissue diagnosis or cytologic diagnosis, whose NSCLCs are locally advanced or metastatic Stage III-B / IV adenocarcinoma, and are inoperable and incurable with radiotherapy.
• Life expectancy of at least three (3) months after the start of administration of the investigational drug.
• Eastern Cooperative Oncology Group (ECOG) performance Score 0 to 2.
• Patients with at least one tumor lesion that can accurately be measured by CT or MRI in at least one dimension with longest diameter to be recorded as no less than double the slice thickness and >=10 mm.
• Patient received at least 6 months EGFR-TKI and show tumor progress
• Adequate hematologic hepatic and renal functions based on the normal conditions of chemotherapy
• Patient signed consent form and adherence and geographic location are liable to follow up

Exclusion criteria

• CNS metastasis
• Active infection
• Bleeding tendency or blood coagulation dysfunction
• History of neurological or psychiatric disorders, including epilepsy, or dementia
• Pregnancy or breast-feeding women
• Organ transplant long-term use of immunosuppressive drugs
• Arrhythmia need anti-arrhythmic treatment or other risk of heart disease
• Use other targeted drugs during the research
• Other conditions may not allowed to join in this study according to the researcher's judgment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Endostar Arm

Experimental group

Description:

Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Recombinant human endostatin 15mg/day, day 1 - 14

Treatment:

Drug: Recombinant human endostatin

Standard Arm

Active Comparator group

Description:

Gefitinib re-challenging, oral daily use Docetaxel 60mg/m2 and Cisplatin 70mg/m2, 21 days Placebo

Treatment:

Drug: Placebo